The Clinical Efficacy Of Roche's Hi-hat Method Combined With Fistula Injection In The Treatment Of Lumbar Disc Herniation

Objective:This research was a multi-center randomized controlled trail of Trampling with Halluces Manipulation combined with Sacral Canal Injection for the treatment of Lumbar Intervertebral Disc Prolapse (LDP). Visual Analogue Scale (VAS) of waist pains and leg pains, lumbar curvature were observed in this trail, in order to objectively evaluate the clinical efficacy and provide reliable evidence for clinical application.Methods:The subjects came from 4 clinical center of ChengDu.320 patients of LDP who accord with the standard of research were included in the trail, then they were randomly divided into two groups:trampling with halluces manipulation combined with sacral canal injection group (Treatment group) and electroacupuncture combined with traction and massage therapy group (Control group), each group (n=160).Treatment group received Luo’s trampling with halluces manipulation combined with sacral canal injection. Control group was given electroacupuncture combined with massage and traction. Two groups of treatment period was 4 weeks, Follow-up evaluations were at 12 and 24 weeks after the beginning of the treatment. The baseline and after treatment of 4,12 and 24 weeks were the evaluation time points; use Visual Analogue Scale(VAS) of waist pains and leg pains, lumbar curvature as observation index; to evaluate each patient. At the sometime, observe the adverse events and safety evaluation. Statistics and analysis of data use spss17.0.Results:1.The baseline analysis:two groups of patients in the group, the basic characteristics, clinical characteristics, degree of illness, the indicators of baseline consistent (P>0.05), good comparability.2.Efficacy Evaluation:(1) After 4 weeks of treatment, the curative effect of classification and total effective rate:comparative differences between the two groups have statistical significance(P<0.05).(2) After 4 weeks of treatment, two groups of waist pain VAS visual analogue scale within the group to compare difference is statistically significant (P<0.05), comparative differences between the two groups have statistical significance(P<0.05).(3)After 4 weeks of treatment, two groups of leg pain VAS visual analogue scale within the group to compare difference is statistically significant (P<0.05), comparative differences between the two groups have statistical significance(P<0.05). (4)After 4 weeks of treatment, the lumbar curvature difference of treatment group was statistically significant (P<0.05); there was no statistically significant difference before and after treatment in the control group of PPS (P> 0.05); comparative differences between the two groups have statistical significance (P <0.05). (5)Follow-up evaluations were at 12 and 24 weeks after the beginning of the treatment, vasWP, vasLP, and lumbar curvature comparing differences between the two groups have statistical significance (P<0.05).3.Safety Assessment:In the two groups were not serious adverse reaction; the incidence of adverse events comparative differences between groups have no statistical significance (P>0.05); Security rating comparative differences between groups have no statistical significance (P> 0.05).Conclusions:1. Two groups have the same effect in treatment of LDP, treatment regimen is safe and effective. The overall treatment effect:trampling with halluces manipulation combined with sacral canal injection group are better than electroacupuncture combined with traction and massage therapy group.2. Follow-up of 4,12 and 24 weeks after treatment, The observation indexes(vasWP, vasLP, lumbar curvature):trampling with halluces manipulation combined with sacral canal injection group (Treatment group) are better than electroacupuncture combined with traction and massage therapy group (Control group)。 In improve of the waist pain, leg pain and lumbar curvature of Lumbar Intervertebral Disc Prolapse, trampling with halluces manipulation combined with sacral canal injection curative effect is better.